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1550nm laser: Indicated for use in surgical applications requiring the vaporization, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including menscus cartilage, in conjunction with an imaging modality for medical specialties including: General Surgery, Orthopedics, Podiatry, Arthroscopy and Spinal Surgery. 980nm laser: Indicated for use to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.

The Regenalase is a portable console that houses a fiber laser operating at 1550 nm wavelength and a diode laser operating at 980 nm wavelength. The system utilizes a wired one-pedal footswitch for hands-free laser activation. The console consists of the 1550 nm laser module, the 980 nm laser module, control electronics, optical module, air cooling, and a touch screen display. The laser energy for the 1550 nm laser is delivered via previously cleared commercially available laser fibers. The fibers come in two different sizes. The 980 nm laser is used with a fiber delivery system, consisting of the Universal Stage One handpiece and four different attachments.

The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories is intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indication: urology, lithotripsy, gastroenterological surgery and gynecological surgery. Urology: • Ablation ofBenign Prostatic Hyperplasia (Hypertrophy) [BPH] • Laser Resection of the Prostate (LRP) • Laser Enucleation of the Prostate (LEP) ● Laser Ablation of the Prostate (LAP) ● Transurethral Incision of the Prostate (TUIP) ● Condylomas ● Urethral strictures ● Lesions of External Gentalia ● Bladder Neck Incisions (BNI) ● Ablation and Resection of Bladder Tumors, and Ureteral Tumors . Endoscopic Fragmentation of Urethral, Ureteral, Bladder, and Renal Calculi ● Treatment of distal impacted fragments remaining in the ureters following lithotripsy Lithotripsy and Percutaneous Urinary Indications: ● Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dihydrate stones ● Endoscopic fragmentation of calculi ● Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed Gastroenterology: Open and endoscopic gastroentery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: • Appendectomy • Angiodysplasia • Polyps • Colorectal Cancer • Biopsy • Telangiectasias • Gall Bladder Calculi • Telangiectasias of the Osler-Weber-Renu Disease • Biliary/Bile duct Calculi • Vascular Malformation ● Ulcers ● Gastric Ulcers ● Esophagitis ● Duodenal Ulcers ● Esophageal Ulcers ● Non Bleeding Ulcers . Varices . Pancreatits . Colitis . Hemorrhoids . Mallory-Weiss Tear . Cholecystectorny . Gastric Erosions . Benign and Malignant Neoplasm Gynecology: Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories are portable thulium fiber lasers intended for incision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories generates non-ionizing radiation which is transferred to the relevant anatomical treatment site through surgical fibers that serve as the delivery vehicle from the laser energy generator to the treatment site. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes wireless (optional) and wired, three-pedal footswitches for hands-free control. The system can utilize an auxiliary video monitor to display operating parameters. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories front panel includes a surgical fiber connection port and a touchscreen with a user interface. The back panel includes electrical and interface cable ports. The Laser Console may be placed on an optional mobile cart. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories includes: - Laser Console ● - Footswitches, wired or wireless (optional) ● - Surgical Fibers ● - . Accessories: - Power cord O - O Video output cable - Video adapter O - Safety glasses O - Fiber stripper O - Fiber cleaver o - Blast shield O - O Interlock connector - Mobile cart (optional) о The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories on emission wavelengths between 1920 and 1960 nm. The IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories can operate at a maximum power output of 60 watts and a maximum frequency output of 2400 Hz with a maximum pulse energy of 6 Joules. The IPG Medical Family of Thulium Fiber Lasers must be operated with the IPG Family of Surgical Fibers. The surgical fibers are flexible optical fibers that deliver the laser energy to the target tissue. The IPG Family of Surgical Fibers are offered in a range of core diameters from 150 microns - 940 microns and include single use, reusable and ball tip options. The surgical fibers are the only patient-contacting components of the IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers and Accessories.